Computers, Networking, Certification, Continued Education, Musician
Peter Hernandez
Systems Management
Mission Viejo,CA
Summary
Diligent management professional with 22+ years of experience making sure products and services meet internal and external requirements and specifications. Skilled in market research, data analytics, project management, technology deployment and integrations, quality compliance/ISO checklists, regulatory affairs and product submissions, writing operating/business procedures, product verification & validation from development through launch, and maintaining optimal business customer relations. Highly organized and analytical with excellent written and verbal communication skills.
Overview
23
23
years of professional experience
4
4
years of post-secondary education
Work History
Quality Systems Program Manager
Medtronic
Minneapolis, MN
06.2022 - Current
- Managed OEM partner EU MDR, UKCA, and Swiss MedDo compliance timelines to facilitate enterprise level mitigation prior to compliance deadlines for all Class I, II, and III products.
- Audited local and region specific quality policies and procedures to ensure conformance with enterprise requirements.
- Responsible for establishing and maintaining good supplier relationships.
- Created summary datasets from several database sources such as SAP, Oracle Agile, Power BI, Excel, etc.
- Created power points and workflows to summarize project status during team meetings.
- Defined various problem statements and solutions to stakeholders.
OEM Integration Manager
Masimo Corporation
Irvine, CA
01.2015 - 05.2022
- Led OEM technology deployment and integration engineering processes.
- Analyzed complex project issues and worked on large enterprise and business-critical applications.
- Researched, recommended, and deployed new technologies and strategies for improving departmental performance and OEM support.
- Provided direct hardware and software engineering support, to OEM project managers and engineering teams worldwide.
- Provided quality compliance and regulatory affairs guidance to OEM partners for market specific certifications and approvals.
- Solved customer challenges by offering relevant products and services.
- Engaged in product training, demonstrations, consumer awareness, branding, and acquisition initiatives to raise awareness and revenues.
- Created and implemented database designs and data models.
- Set up and controlled user profiles and access levels for each database segment to protect important data.
- Evaluated software protocols to determine compatibility with existing systems.
- Diagnosed and resolved hardware and software issues (component/code level).
OEM Deployment Engineer
Masimo Corporation
Irvine, CA
02.2007 - 05.2015
- Translated customer requirements into written use cases.
- Designed customized solutions for proposals to potential customers.
- Designed intuitive graphical user interfaces to improve user experience.
- Managed use of various types of databases and configured, installed and upgraded new ones.
- Documented technical workflows and knowledge to educate newly hired employees.
- Participated in system development life cycle from requirements analysis through system implementation.
- V&V tested finished products to identify any potential issues prior to deployment, develop solutions and collaborate with developers on solution implementation.
Sustaining Engineer
OEM, Integrated Medical Systems, Inc
Signal Hill, CA
01.2000 - 02.2007
- Performed concurrent design and manufacturing engineering and other functions to reduce time required to bring product to market.
- Resolved technical and quality issues by collaborating with customer, manufacturing, quality assurance, vendors and supplier personnel.
- Developed streamlined manufacturing process, which boosted productivity.
- Managed design and manufacturing teams to build proprietary process equipment within aggressive cost and time constraints.
- Designed V&V tests of finished product to check for quality.
Education
Bachelor of Science - Electronic Engineering
ITT Technical Institute
Anaheim, CA 06.1998 - 06.2002
Skills
SAP, Oracle Agile, Salesforce, Power BI, SQL, Tableau, Jira, Confluence
Microsoft Office Specialist, Master Certification
ISO13485, ISO14971, MDR 2017/245, MDD 93/42/EEC, ISO60601, ISO9001, ISO80601-2-61, ISO 80601-2-55
Data-driven Decision Making, Data Analysis
Lean Six Sigma Familiarity/Internal Auditing
Standard Operating Procedures & Business Procedures
Executive Summaries
Problem-solving abilities & Project Planning
Electronic Engineering
Product Development, Launch, & Management
Excellent Written Communications
Organization and Time Management
Analytical and Critical Thinking
Technical Analysis, Schematic & CAD reviews
Compliance & Regulatory Expertise
Global Cultural Awareness
Self-Motivated, Self-Starter
Interdisciplinary Collaboration
OEM Technology Integrations
Interests
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Nothing in life is to be feared. It is only to be understood.
Marie Curie
Timeline
Quality Systems Program Manager
Medtronic
06.2022 - Current
OEM Integration Manager
Masimo Corporation
01.2015 - 05.2022
OEM Deployment Engineer
Masimo Corporation
02.2007 - 05.2015
Sustaining Engineer
OEM, Integrated Medical Systems, Inc
01.2000 - 02.2007
Bachelor of Science - Electronic Engineering
ITT Technical Institute
06.1998 - 06.2002